PMA
P140019: I-FACTOR PEPTIDE ENHANCED BONE GRAFT
FDA PMA · Filler, bone void, synthetic peptide · Cerapedics, LLC
Key facts
| PMA number | P140019 |
|---|---|
| Trade name | I-FACTOR PEPTIDE ENHANCED BONE GRAFT |
| Generic name | Filler, bone void, synthetic peptide |
| Applicant | Cerapedics, LLC |
| Owner/operator | Cerapedics, Inc. |
| Product code | NOX |
| Approval date | Nov 3, 2015 |
| Docket number | 15M-4343 |
| Notice date | Nov 30, 2015 |
| Establishment registration | 3007155473 |
| FEI number | 3007155473 |
At a glance
- 10–99 Supplements
- Sep 16, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: